- Ensure materials, components, processes, and manufacturing technique produce high-quality, reliable products.
- Develop and/or assess quality inspection criteria for incoming inspection and in-process inspection to minimize risk.
- Inspect materials, equipment, processes, and products to verify conformance with specifications.
- Develop and implement methods for sampling, inspection, defect recognition, product testing and evaluation, and SPC trending utilizing statistical, engineering and quality knowledge.
- Apply statistical techniques to receiving inspection, manufacturing, and validation processes. Using statistical tools in Microsoft Excel or other SPC software.
- Interface with Production to assure that quality considerations and requirements are adequately covered in manufacturing procedures, equipment selection, design, validation, and training.
- May maintain equipment/instrument calibration log and coordinate equipment/instrument calibrations.
- Participate in solicitation, definition and review of customer specifications, product requirements, design specifications, verification and validation testing and risk assessment activities.
- Lead cross-functional teams and manage investigations into product complaints and reported quality issues. Works with suppliers, management, Engineers, and Manufacturing associates in the resolution of quality issues.
- Lead the CAPA program including leading review board and CAPA & continuous improvement projects.
- Provide training and support to quality assurance team members, focusing on systems, policies, procedures, and core processes.
- Effectively communicate and interact with customers.
- Support Quality Objectives, including analysis and regular trending of key quality system elements.
- Bachelor's degree in a scientific or engineering field is required.
- Minimum 3 years' experience in a quality engineering role in the medical device industry, or a related industry with manufacturing and assembly processes.
- Experience working in a regulated environment such as medical device and with a Quality Management System (ISO 9001, ISO 13485, FDA QSR, cGMP 21 CFR Part 820, ISO
- Proficient with Microsoft Office Suite
- Computer proficiency, including database management
- Excellent written and verbal communication skills
- Proficient in English, both written and verbal
- Deep knowledge of quality assurance terminology, methods, and tools
- Excellent analytical, problem-solving, and decision-making skills
- Demonstrated knowledge of testing best practices, version-control procedures, and defect management processes
- Ability to manage multiple projects within various disciplines, in a fast-paced environment.
- Experience with advanced SolidWorks or 3D CAD techniques preferred.
- Professional certification, such as Six Sigma, CQE (certified quality engineer), or CQA (certified quality auditor), preferred.
- Begin your journey to a healthier future with enrollment in medical, dental, vision, disability, and life insurance, starting the first of the month after date of hire.
- Secure your financial well-being with a 401k enrollment accompanied by an employer match after 30 days of employment.
- Enjoy competitive PTO accrual and a well-deserved Holiday schedule, ensuring work-life balance.
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Quality Engineer - Maryland Heights, United States - Healthcare Components Group
Description
This position is located at our facility in Maryland Heights, MO.Overview
Working as a Quality Engineer provides an exciting opportunity to contribute to cutting-edge technologies and precision-driven products. Your expertise and dedication in handling microscopic components will directly impact the quality and success of our final products. If you thrive in a detail-oriented and challenging environment, this role might be the perfect fit for you.
SUMMARY OF PRIMARY DUTIES AND RESPONSIBILITIES:
The Quality Engineer is primarily responsible for ensuring materials, components, processes and manufacturing techniques produce high-quality, reliable products. Implementing methods to inspect, test, and evaluate products and the reliability of manufacturing processes. Helping to create solutions as part of a team.
Essential Duties & Responsibilities:
The ideal candidate for this role will have the following qualifications:
